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Clinical Trials in France / NCT06499363
Recruiting Observational

Treprostinil in Newborns With Pulmonary Hypertension; a Non-Interventional Study to Collect Data on Drug Utilization, Safety, and Effectiveness

NCT06499363 · tracked via the Priya Life Science France tracker
Sponsor
Ferrer Internacional S.A
Phase
Observational
Started
2025-02-25
Last updated
2025-09-03

Condition(s) studied

Persistent Pulmonary Hypertension of Newborn

Study summary

This observational study will seek to describe the uses and safety and efficacy outcomes of treprostinil in clinical practice in patients with persistent pulmonary hypertension (PPHN).

Eligibility

Sex
ALL
Min age
—
Max age
44 Weeks
Healthy volunteers
No
Inclusion Criteria: 1. Newborn infants who received at least one dose of IV or SC treprostinil as per clinical practice within 5 years from the moment of data collection. 2. Aged up to 44 weeks after conception at treprostinil initiation. 3. Pulmonary hypertension (PH) or suspicion of PH at the moment of treprostinil initiation. 4. Parent(s) or legally authorized representative(s) provides non-opposition consent for the patient participation in the study. 5. Newborn infants affiliated to French social security. Exclusion Criteria: * None.

Primary outcome measure(s)

  • Characteristics of neonates receiving treprostinil in the clinical practice. — From baseline to Day 30 after last dose of treprostinil
    Sex (male/female) ; Gestational Age (weeks) ; Birth Weight (g) ; Apgar (1 and 5 min, 0-10) and Time from birth to treprostinil initiation (h)
  • Treprostinil-specific treatment patterns. — From baseline to Day 30 after last dose of treprostinil
    Prior concomitant treatments, treprostinil route, treprostinil dose(s) (mg/ml) and treprostinil treatment duration (days).
  • Number of participants with treatment-related adverse events to evaluate safety. — From baseline to Day 30 after last dose of treprostinil

Trial sites (4)

FacilityCityRegionStatus
CHU Lyon (HCL) - Hopital Femme Mère Enfant Bron France Recruiting
Réanimation néonatale CHU Grenoble Alpes - Hôpital Couple Enfant Grenoble France Recruiting
CHU Lille - Clinique de Néonatalogie Lille France Recruiting
CHU de Toulouse Hopital des enfants - Réanimation Néonatale Toulouse France Recruiting

More Ferrer Internacional S.A. trials in France

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of FNP-223 to Slow Progression of Progressive Supranuclear Palsy (PSP) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06499363 on ClinicalTrials.gov ↗ ← All trials in France